U.S. patent number 5,425,355 [Application Number 07/646,948] was granted by the patent office on 1995-06-20 for energy discharging surgical probe and surgical process having distal energy application without concomitant proximal movement.
This patent grant is currently assigned to Laserscope. Invention is credited to Michael I. Kulick.
United States Patent |
5,425,355 |
Kulick |
June 20, 1995 |
Energy discharging surgical probe and surgical process having
distal energy application without concomitant proximal movement
Abstract
This invention relates to a surgical instrument. Specifically, a
surgical instrument is disclosed which dispenses incising,
transecting, or tissue treating energy to a body site or part
undergoing an operation or treatment where energy is discharged
from a conduit to effect the treatment. The disclosed instrument is
inserted to an operative site that effectively rules out proximal
manipulation of the instrument. Therefore, proximal insertion with
subsequent distal manipulation excluding proximal side-to-side or
up and down manipulation is disclosed. The disclosure further
includes a deployable shield and is ideal for operative engagement
to surgical sites on the body such as the carpal tunnel, tarsal
tunnel, the wrist, temporomandibular joint, or scar tissue capsules
forming around implants of the breast.
Inventors: |
Kulick; Michael I. (San
Francisco, CA) |
Assignee: |
Laserscope (San Jose,
CA)
|
Family
ID: |
24595110 |
Appl.
No.: |
07/646,948 |
Filed: |
January 28, 1991 |
Current U.S.
Class: |
600/183; 604/22;
606/13; 606/14; 606/15; 606/16; 606/17 |
Current CPC
Class: |
A61B
17/320036 (20130101); A61B 18/24 (20130101); A61B
17/0218 (20130101); A61B 2017/22052 (20130101); A61B
2217/005 (20130101); A61B 2217/007 (20130101); A61B
2218/008 (20130101) |
Current International
Class: |
A61B
17/32 (20060101); A61B 18/20 (20060101); A61B
18/24 (20060101); A61B 17/22 (20060101); A61B
18/00 (20060101); A61B 17/02 (20060101); A61M
1/00 (20060101); A61B 001/00 () |
Field of
Search: |
;606/7,10,13-17,170-171
;128/395,397-398,4,749,750-754 ;604/96,27,22 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
3M Health Care Brochure, dated Oct. 1989, "Agee Inside Job Carpal
Ligament Release System". .
Sandzen, AFP, Nov. 1981, "Carpal Tunnel Syndrome". .
Smith, Arch. Phys. Med. Rehabil. Sep. 1977, "Carpal Tunnel
Syndrome". .
MacDonald, Journal of Hand Surgery, undated, portion of article on
Carpal Tunnel Syndrome. .
Yamaguchi, et al., Minnesota Medicine, Jan. 1965, "Carpal Tunnel
Syndrome"..
|
Primary Examiner: Green; Randall L.
Assistant Examiner: Zuttarelli; P.
Attorney, Agent or Firm: Banner, Birch, McKie &
Beckett
Claims
What is claimed is:
1. A probe apparatus for surgery in an operating site having narrow
substantially non manipulable entrance confines inhibiting
side-to-side motion of said probe comprising:
a probe having a closed blunt non dissecting tip and defining at
least one interior conduit having an opening at a distal end, said
blunt dissection tip including means for creating a space between
tissues in the body of sufficient dimension to facilitate the
surgery without interference from collapse of the tissues about the
probe;
a suction entrance defined in said space, said suction entrance
defined behind said blunt dissection tip of said probe about said
space for operation at said distal end of said probe;
an optical viewing device within said probe, said optical viewing
device providing visualization of said space for overlying said
suction entrance for view at said end of the probe;
means for viewing from said optical viewing device disposed to said
end of said probe; and
means for grasping disposed to said end of said probe for grasping
tissue or structures at said operating site within the view of said
optical viewing device whereby said probe may remotely manipulate
said grasped tissue or structures at said operating site.
2. The invention of claim 1 and further including:
a non penetrating conduit for energy discharge for transection,
incision or treatment at said operating site, said conduit
protruding above the suction entrance at said end of said probe and
terminating in said field of view of said optical viewing device
for the discharge of said energy;
means for supplying energy to said non penetrating conduit for
energy discharge for transection, incision or treatment at said
operating site;
means for manipulating said non penetrating conduit for energy
discharge for transection, incision or treatment with respect to
said end of said probe overlying said suction entrance in the view
of said optical device at said operating site.
3. The invention of claim 1 and wherein:
said means for grasping is rotatable.
4. A process for surgery utilizing a probe, said probe being a
multichannel probe of sufficient rigidity to be insertable in a
narrow entrance of an operating site, and without side-to-side and
up and down manipulation accommodate blunt dissection of anatomical
structures without incising them, said probe having an operating
portion for insertion to a position within a patient and a proximal
controlling portion for insertion and withdrawal of said probe from
a position exterior of said patient, said operating portion having
a closed blunt non dissecting tip and a cavity axially displaced
behind said tip and shielded thereby for location to said operating
site, said probe further having a vision device disposed at said
cavity, said vision device having a field of view at said cavity
when said probe is within said patient and including a conduit to
the proximal manipulation portion for transmitting a view from said
cavity of said non dissecting tip to said position exterior of said
patient, said probe having a non penetrating conduit for energy
discharge for transection, incision or treatment from the proximal
controlling portion of said probe exterior of said patient to said
operating site of said non dissecting tip within said patient, and
said probe having means disposed at a distal end of said non
dissecting tip for controlling a relative direction of the energy
discharging conduit relative to an operating space of said tip
within the field of view of said viewing device, said means
enabling change of relative direction of said energy discharging
conduit with respect to said operating space behind said non
dissecting tip, said process including a series of steps
comprising:
inserting said probe to said operating site thus creating a space
between tissues in the body of sufficient dimension to facilitate
the surgery without interference from collapse of the tissues about
said probe, said axial insertion continuing until said cavity
behind said non dissecting tip is at said operating site;
visualizing said operating site with said optical viewing
device;
supplying said non penetrating conduit with energy discharge for
transection, incision or treatment to said operating site during
said visualization step; and
manipulating said non penetrating conduit through said means for
manipulating said energy discharging conduit in treatment at said
operating site without concomitant proximal side-to-side
manipulation of said probe at said proximal controlling portion of
said probe.
5. The process of claim 4 and wherein said insertion step occurs to
said operating site within said narrow substantially non
manipulable entrance confines inhibiting side-to-side motion of
said probe, selected from the class of operating sites
including:
carpal tunnel, tarsal tunnel, wrist joint, elbow joint, ankle
joint, temporomandibular joint, or shoulders, between natural
anatomic tissue planes or scar tissue capsules forming around
implants of the breast.
6. The process of claim 4 and wherein said non penetrating conduit
for energy discharge for transection, incision or treatment
includes:
providing an optical fiber; and,
said supplying step includes:
supplying said optical fiber with lasing energy.
7. The process of claim 4 and wherein said inserting step into the
operating site adjacent said constrained space includes:
irrigating and/or ventilating said operating site.
8. The process of claim 4 and wherein said inserting step into the
operating site adjacent said constrained operating space includes
inserting said probe into the female breast of the human anatomy
between the interface of a breast implant and a scar tissue capsule
around said breast implant.
9. A probe apparatus for surgery in an operating site having narrow
substantially non manipulable entrance confines inhibiting
side-to-side motion of said probe comprising:
a probe defining at least one interior conduit having an opening at
a distal end, said distal end being insertable into said
entrance;
a closed blunt non dissecting tip attached to an end of said probe
including means for creating a space between tissues in the body of
sufficient dimension to facilitate the surgery without interference
from collapse of the tissues about said probe;
an optical viewing device within said probe, said optical viewing
device providing visualization of said space for providing a field
of view of said space;
a non penetrating conduit for energy discharge for transection,
incision or treatment at said operating site, said conduit working
within said space at said end of said probe behind said closed
blunt non-dissecting tip and terminating in said field of view of
said optical viewing device for the discharge of said energy;
means for supplying energy to said non penetrating conduit for
energy discharge for transection, incision or treatment at said
operating site; and
means for viewing disposed to said end of said probe during the
discharge of energy from said conduit;
said means for defining a space including an expansible and
contractible shield mounted to said blunt non dissecting tip of
said probe, said shield being movable between a collapsed
disposition conformed along a side of said probe to an expanded
disposition with respect to said side of said probe whereby said
shield may be collapsed with respect to said probe during insertion
and expanded when said shield is at said operating site to define
said space behind said blunt non-dissecting tip; and
means for expanding and contracting said shield attached to said
probe.
10. The apparatus of claim 9 and wherein said shield comprises:
a flexible mesh structure disposed about the exterior of said
probe;
means for attaching a first portion of said flexible mesh structure
at a first location on said probe;
means for attaching a second portion of said flexible mesh
structure to a reciprocating portion of said probe whereby upon
relative movement between said reciprocating portion of said probe
and said first location on said probe said flexible mesh structure
expands and contracts about said probe.
11. The apparatus of claim 9 and wherein said shield includes:
a balloon disposed about the exterior of said probe;
a conduit communicated to said balloon on said probe; and,
means for expanding and contracting said balloon from through said
conduit relative to said probe whereby said shield can be expanded
upon insertion to said operating site.
12. The apparatus of claim 9 and wherein said means for supplying
includes:
means for supplying lasing energy to said conduit; and,
said conduit is a fiber.
13. The apparatus of claim 9 and including:
a suction conduit within said probe, said suction conduit
protruding from the opening of said probe to a location distal to
optical viewing device; and,
means for providing suction to said suction conduit.
14. The apparatus of claim 9 and wherein said probe includes a
pistol-type grip at one end and said opening at said opposite end,
and said probe is rotatable with respect to said grip.
15. The apparatus of claim 9 and wherein:
means for moving said energy conduit with respect to said opening
in said probe whereby said conduit can be moved with respect to
said view of said optical viewing device.
16. The apparatus of claim 15 and wherein said moving means
includes:
means for moving said conduit in and out of said probe.
17. The apparatus of claim 15 and wherein said means for moving
includes:
means for steering said conduit with respect to said probe.
18. A probe apparatus for surgery in an operating site having
narrow substantially non manipulable entrance confines inhibiting
side-to-side motion of said probe comprising:
a probe having a closed blunt non dissecting tip at a distal end,
said blunt non dissecting tip having means for creating a space
between tissues in the body of sufficient dimension to facilitate
the surgery without interference from collapse of the tissues about
the probe;
said probe defining at least one interior conduit having an opening
at said means for defining a space;
a suction entrance defined in said space;
an optical viewing device within said probe, said optical viewing
device providing visualization of into said space behind said
closed blunt non dissecting tip of said probe for providing a field
of view at said end of said probe;
a non penetrating conduit for energy discharge for transection,
incision or treatment at said operating site within said probe,
said conduit protruding to the suction entrance at said end of said
probe and terminating in said field of view of said optical viewing
device for the discharge of said energy;
means for supplying energy to said non penetrating conduit for
energy discharge for transection, incision or treatment at said
operating site; and
means for manipulating said non penetrating conduit for energy
discharge for transection, incision or treatment with respect to
said end of said probe overlying said suction entrance in the view
of said optical device at said operating site.
19. The apparatus of claim 18 and wherein:
means for cleaning said non penetrating conduit for energy
discharge for transection, incision or treatment is disposed at
said end of said probe.
20. The apparatus of claim 18 and including:
means for moving said energy conduit in and out of said probe.
21. The apparatus of claim 18 and wherein said means for moving
includes:
means for steering said optical device with respect to said
probe.
22. The apparatus of claim 18 and wherein said means for supplying
includes:
means for supplying lasing energy to said conduit; and,
said conduit is an fiber.
23. The apparatus of claim 18 and wherein said probe includes a
pistol-type grip at one end and said opening at said opposite
end.
24. The apparatus of claim 18 and wherein said means for defining a
space behind said blunt non dissecting tip includes:
an expansible and contractible shield mounted to said probe, said
shield moveable between a collapsed disposition conformed along
side of said probe to an expanded disposition with respect to the
side of said probe whereby said shield may be collapsed with
respect to said probe during insertion and expanded when said
shield is at or creating said operating site to create a space;
and
means for expanding and contracting said shield attached to said
probe.
25. The apparatus of claim 24 and wherein said shield
comprises:
a flexible mesh structure disposed about the exterior of said
probe;
means for attaching a first portion of said flexible mesh structure
at a first location on said probe;
means for attaching a second portion of said flexible mesh
structure to a reciprocating portion of said probe whereby upon
relative movement between said reciprocating portion of said probe
and said first location on said probe said flexible mesh structure
expands and contracts about said probe.
26. The apparatus of claim 24 and wherein said shield includes:
a balloon disposed about the exterior of said probe;
a conduit communicated to said balloon on said probe; and,
means for expanding and contracting said balloon from through said
conduit relative to said probe whereby said shield can be expanded
upon insertion to said operating site.
Description
This invention relates to a surgical instrument. Specifically, a
surgical instrument is disclosed which dispenses incising,
transecting, or tissue-treating energy to a body site or part
undergoing an operation or treatment where energy is discharged
from the end of a conduit to affect the treatment. The disclosed
instrument is inserted in an operative site that effectively rules
out proximal manipulation of the instrument. Therefore, proximal
insertion with subsequent distal manipulation excluding
side-to-side proximal manipulation is disclosed. The disclosure
further includes a deployable shield and is ideal for operative
engagement to surgical sites on the body such as the carpal tunnel,
tarsal tunnel, the wrist, elbow, ankle, temporomandibular joint, or
scar tissue capsules forming around implants of the breast.
BACKGROUND OF THE INVENTION
Surgery accomplished with the use of energy discharging probes is
well known. Examples of such energy discharging probes include
surgical instruments operating upon the knee and laparoscopes for
operative insertion into the abdomen. These instruments are all
inserted into an incision and thereafter manipulated proximally
(exterior of the patient) to move their distal end (interior of the
patient) to the operating disposition at the intended internal site
of the surgery.
The body, however, contains many surgical sites where the insertion
of a probe is constrained. That is to say, that although the probe
is conveniently inserted along a constrained path at many surgical
sites, it cannot be manipulated proximally to achieve the desired
surgical result because the space into which it was inserted is so
restrictive it does not otherwise accommodate gross side-to-side
motion (or even rotation) of the probe without significant risk of
injury to vital structures. In other words, once the surgical probe
is in place, it cannot be moved about easily, other than the
original "in-and-out" motion by which insertion to the surgical
site occurred in the first place. Transecting of the transverse
carpal ligament for the relief the carpal tunnel syndrome is an
example of such surgery where movement of a probe is severely
restricted.
The carpal tunnel syndrome is a well established symptom complex
resulting from median nerve compression at the wrist. Referring to
FIGS. 1 and 2, the carpal tunnel T is located on the palmar aspect
of the wrist (carpus or wrist bones) (see aspect of FIG. 1) between
the distal wrist flexion crease 14 and roughly the mid palm. The
anatomy of the carpal tunnel in its contents is shown in relation
to the surface structures in the section of FIG. 2. The median
nerve 20 is superficial on the radial aspect of the flexor tendons
24 and branches, just distal to the distal border of the transverse
carpal ligament L. Those familiar with anatomy will know that four
superficial flexors, four deep flexors, the flexor pollicis longus
and the median nerve normally travel through this tunnel.
Three of four boundaries of the carpal tunnel are essentially
inelastic (see bones B in FIG. 2). The dorsal, radial, and ulnar
borders form the U-shaped configuration which is open palmarly. The
fourth side, the palmar side, consists of the transverse carpal
ligament.
Any condition, systemic or local, which reduces the normal
available cross-sectional area of the carpal tunnel--either by
increasing the volume of contents or by decreasing the diameter of
the tunnel--causes local constriction of the median nerve (the
structure most sensitive to compression). The most common symptoms
are those of sensory abnormalities in the median nerve distribution
of the hand. See 20, FIG. 1. These include hyperesthesia (acute
irritating hypersensibility), paresthesia (burning, tingling "pins
and needles" sensation), hypoesthesia (decreased sensibility) and
pain.
Surgery is indicated for cases of carpal tunnel syndrome retracting
to conservative care, particularly those with obvious muscle
atrophy of the median enervated thenar muscles. The purpose of the
surgery is two-fold: (1) to release external pressure on the median
nerve and (2) to diagnose and treat the pathology responsible for
the nerve compression.
The tarsal tunnel has surgical problems analogous to the carpal
tunnel.
As is well known to those specializing in hand surgery, problems
exist upon surgery in the wrist. Simply stated, the joint
interfaces at the wrist manifest with problems such as tears in the
triangular fibrocartilage, chondromalacia, arthritis, irregularity
in the articular surface, synovitis, and loose bodies floating in
the joint, causing pain.
The elbow is analogous to the wrist, except that the elbow does not
have triangular fibrocartilage or the problems associated with
it.
Similarly, the ankle has surgical problems comparable to those of
the elbow.
The temporomandibular joint has surgical problems similar to those
of the wrist, with the additional complication associated with
disease states of the articular disc (meniscus), and scar tissue
adhesions.
Conventional treatment as performed in other joints (i.e., the
knee) is difficult or prohibitive in the wrist, ankle, elbow, and
temporomandibular joint because of the severe limitation of space
within these joints, making the positioning of multiple
visual/therapeutic devices to the injury site impossible without
causing iatrogenic injury.
Breast surgery is another procedure where the apparatus and process
of this invention is applicable.
Breasts are augmented or made larger by an implant. The implant is
a foreign body. All foreign bodies have scar tissue deposited
around them. When the scar tissue is deposited and either contracts
or shrinks, the breast implant becomes hard. This causes a
disfigurement in the breast shape, and if the scar tissue grasps a
nerve or if an otherwise hard distended implant impinges upon a
nerve, this causes pain.
Conventional treatment includes two procedures. The first is closed
capsulotomy where one squeezes the breast and bursts the breast
capsule. This is ineffective because the implant can also pop. This
procedure can also causes pain to the patient and pain to the
surgeon.
The second procedure is the so-called open capsulotomy. In this
procedure an incision is made, and the surgeon deflates and removes
the implant under direct inspection. Thereafter, surgical entry is
made into the evacuated capsule with at least two or three
instruments, and the surgeon cuts the capsule, recreating a large
pocket. Thereafter, a new implant is inserted. This latter
procedure increases cost, prolongs the operation, and increases
morbidity, including the potential for bleeding (and scarring).
Laser surgery has been used in other body sites before. Most
commonly, and analogously with respect to this invention is laser
surgery on various joints within the body, especially on the
knee.
Most sites in the body have the advantage of providing proximal
manipulation of the operating instrument, especially the knee. That
is to say, the surgeon by the manipulation of the device external
to the patient, gets the operative end of the device internal of
the patient to move to an operating position. Another example of
such an instrument is a laparoscope, an instrument utilized in
operations on the abdomen and, in particular, the gallbladder.
Typically, the laparoscope is a multichannel instrument carrying a
fiber probe for discharging surgical energy in one channel and an
optical viewing fiber in another channel. Additionally, it is
common with such devices to provide for suction, irrigation, and a
tube for the insertion and removal of various tissue grasping
devices. There are usually done through separate openings leading
to the operation site.
In a laparoscope, the energy discharging fiber at the end of the
probe can be moved within the field of view provided by the fiber.
The energy discharging fiber is arrayed parallel to the
longitudinal axis of the probe. At the tip of the probe, there is
defined a fiber end holding section of the probe which raises and
lowers with respect to the elongate axis of the probe.
In surgery, the physician first points the entire probe in the
direction of or at the surgical site. The surrounding anatomy of
the patient is conformable; it permits the probe to be moved
relative to the patient until the operative tip is near the
surgical site. Thereafter, and when the probe is adjacent to the
surgical site, the surgeon raises or lowers the fiber end holding
section of the laparoscope to the angle necessary to direct the
surgical energy discharged from the tip of the fiber. Thereafter,
the entire probe is rotated to direct the energy discharging fiber
to the correct angle relative to the axis of the probe for the
surgery.
The reader will understand that the above-mentioned surgical
techniques for parts of the body where a probe may be manipulated
proximally are simply not applicable to restricted operating sites
in the body where the probe is constrained, particularly carpal
tunnel surgery, tarsal tunnel surgery, surgery of the wrist, ankle
or elbow, surgery of the temporomandibular joint, and surgery on
breast capsules after augmentation. Moreover, in the case of breast
implants, actual surgery between the interface of the implant scar
tissue capsule and the implant must occur without damage to either
the implant or the anatomy adjacent the capsule.
SUMMARY OF THE INVENTION
An apparatus and concomitant process for surgery utilizing a probe
for the discharge of incising, transecting or tissue treatment
energy is disclosed, the probe being adaptable for the surgical
process when the constraints of the anatomy through which the probe
is inserted substantially inhibit or prevent proximal manipulation
of the probe. The disclosed instrument and related process is
particularly useful in a process for surgery on the transverse
carpal ligament of the hand, tarsal tunnel surgery, surgery in the
wrist, ankle, or elbow, surgery in the temporomandibular joint, or
breast capsule surgery with breast implants in place.
The probe defines at least one interior rigid or semi-rigid conduit
having an opening, this opening being preferably at the distal end
of the probe. The probe is either rigid or semirigid. For example,
in the case of carpal tunnel surgery, the probe is given sufficient
length for insertion into the hand with said opening disposed
within the carpal tunnel to provide access to the hand.
The interior conduit of the probe includes an optical viewing
device. This optical viewing device protrudes from the opening of
the probe for view at the end of said probe. Optimally, the viewing
device is stationary with respect to the probe; optionally, the
viewing device can be provided with remote motion with respect to
the probe.
The probe is provided with at least one conduit for conducting
energy sufficient for the transection, incision, or treatment of
the surgical site of the body where probe insertion occurs and
terminates in the field of view of the viewing device. This is
required so that the conduit may be observed at the interface of
energy application during the discharge of energy.
There is required means for the distal manipulation of the conduit
releasing the transecting, incising or treatment energy at the end
of the probe without concomitant proximal manipulation of the
probe, other than along the original "in-and-out" and rotational
path through which surgery occurred.
According to the process of this invention, when the probe is
inserted at the surgical site, the surgical site is such that
side-to-side motion of the probe relative to the path of insertion
of the probe is prohibited--other than the original path of
insertion and any motion of rotation along the axis of the probe.
Once such entry has been accomplished, the surgical site is
visualized. For example, where the surgical site is the carpal
tunnel in the wrist, the transverse carpal ligament is sighted
through said optical viewing device at the opening in said probe
from the carpal tunnel to and toward the palmar side of the hand.
As a further example, where the capsule of a breast implant
requires surgery, the scar tissue capsule is visualized at portions
of the capsule where incisions are to be made.
Without proximal side-to-side manipulation, and during the
visualization, energy for transecting, incising or treating the
surgical site is introduced. The introduction and local direction
of the energy occurs once the probe is inserted; without the
proximal manipulation of the probe side-to-side only motion in the
"in-and-out" or rotation mode is provided from the proximal end of
the device mode. As will be apparent in the "pistol grip"
embodiment shown, rotation of the probe with respect to the pistol
grip is contemplated.
A deployable shield is provided on the probe. This deployable
shield is moveable from a contracted disposition relative to the
probe to an expanded disposition relative to the probe. Preferably,
one extremity of the deployable shield is rigidly attached to the
probe. Another extremity of the deployable shield is affixed to an
actuating member on the probe. When the probe is inserted, the
shield is collapsed. When the probe is at the surgical site, the
shield is expanded.
The deployable shield has two functions. First, the shield prevents
portions of the anatomy at the surgical site which are not intended
for surgery to be restricted away from the surgical site. Secondly,
the shield effectively prevents the discharged energy from
affecting healthy nearby tissue which is not intended to be
transected, incised or treated.
In one embodiment of this invention, there is provided a protective
flexible mesh structure disposed about the exterior of said probe.
This protective flexible mesh structure includes semirigid woven
struts forming the side walls of the collapsible flexible mesh
structure. The flexible mesh structure is attached at one end of
the probe, preferably at the distal end. The flexible mesh
structure is attached at the opposite end to a reciprocating member
moving along the probe, preferably at an exterior sleeve.
In operation, the reciprocating member, preferably a sleeve, is
collapsed onto the probe during the insertion of the probe. Once
the instrument has reached the surgical site, the flexible mesh
structure is expanded about the probe prior to the supplying of
energy to the surgical site.
In an alternate embodiment, a balloon is disposed about the
exterior of the probe. This balloon is collapsed to the probe
during insertion of the probe. Once the probe reaches the surgical
site, the balloon is expanded. In the expanded disposition, the
balloon physically screens out anatomy from the surgical site.
It will be understood that the side walls of the balloon are
capable of being opaque to the energy discharged at the surgical
site. Moreover, and because of the physical separation from the
surgical site, shielding of other portions of the anatomy occurs
from full effect of the radiation occurs.
The disclosed instrument and shield are especially designed for
deployment in extremely restricted anatomical volumes. Such volumes
are found in the carpal tunnel, the joints of the wrist, ankle and
elbow, the tarsal tunnel, the temporomandibular joint, or at the
interface of a breast capsule and breast implant. It will be
understood that once the shield is deployed, manipulation of the
probe is further restricted; in short, the expanded volume of the
shield attached to the probe further limits the ability to
proximally maneuver the probe so that the energy discharging
portion of the probe will not damage tissue beyond the surgical
site.
Because of this disability, it is required that the conduit for the
discharge of the energy be completely maneuverable at the distal
end of the probe without concomitant proximal manipulation.
Accordingly, two embodiments are provided.
In a first embodiment, the energy discharge conduit is encased
within a second conduit which itself can be directed with respect
to the probe. According to this embodiment, the energy discharging
conduit includes a semirigid conduit having stiff tensile members
in the side walls of the semirigid conduit. Preferably, at least
two such members are utilized so that the energy discharging
conduit can move up and down and side to side with respect to the
probe.
In a second embodiment, the conduit from which the energy is
discharged is threaded interior to the conduit on which the shield
is disposed. This interior conduit has a member which can dispose
the energy discharging conduit at an adjustable angle with respect
to the end of the probe. By the expedient of moving the energy
fiber to the requisite angle with respect to the axis of the probe,
and rotating the interior conduit with respect to the exterior
conduit, complete positioning of the conduit discharging the energy
to the surgical site can occur.
The reader will understand that the disclosed concentric conduits
have additional utility. For example, they can be utilized for
either ventilation, irrigation, and suction to or from the site of
the surgery.
It will be understood that the functions of suction and irrigation
are not to be casually treated in this disclosure. It will be
understood that the because the surgical probe herein disclosed is
confined to such a tight volume or surgical interface, suction at a
minimum is required to preserve vision of the transection, incision
or treatment. Further, the suction is disposed with respect to the
probe in such a disposition that the suction of fluids is away from
the line of sight between the optical viewing device and the
interface of surgery.
BRIEF DESCRIPTION OF THE DRAWINGS
Other objects, features and advantages of this invention will
become more apparent after referring to the following specification
and drawings in which:
FIG. 1 is a palmar view of the a right hand with surgically
important structures noted on the exterior of the hand;
FIG. 2 is a cross section of the wrist at the level of the hook of
the hamate illustrating the anatomy of the carpal tunnel and its
contents;
FIG. 3 is a perspective view of the probe of this invention
attached to a pistol grip;
FIGS. 4A and 4B are respective side elevation and plan views of the
disclosed probe with connection here being shown in FIG. 4A to
remote viewing, lasing, and suction devices;
FIGS. 5A, 5B and 5C are respective perspective, side elevation and
plan views of the tip of the probe illustrating the relationship of
the suction device distally from the end of the probe for the
withdrawal of smoke and soot from the surgical site and away from
the view of the fiber-optic device and the surgical procedure at
the energy discharging conduit;
FIG. 6 is a perspective illustration of the operative energy
discharging fiber encased within a directionally steerable outer
sheath such as that found on endoscopes, with the control structure
to the tip of the directionally steerable structure being
schematically shown;
FIG. 7 is a perspective view of the semirigid probe illustrating
the insertion of a grasping and manipulating surgical appliance in
the combination of the disclosed probe, the schematic format here
shown omitting the pistol type handle for ease of understanding,
this illustration setting forth in perspective view a deployable
shield in the form of an expansible balloon;
FIG. 8 is a side elevation section at the end of the probe along
lines 8--8 of FIG. 7 illustrating the relative elevations of the
appliance members and illustrating the balloon as an inflated
structure for performing the surgery disclosed;
FIG. 9A is a perspective view of an alternate embodiment of the
probe including a collapsible flexible mesh structure, the flexible
mesh structure here being shown in the collapsed position on the
exterior of the probe for insertion of the probe to the surgical
site at the transverse carpal ligament;
FIG. 9B is a perspective view of the alternate embodiment of the
probe showing the collapsible flexible mesh structure expanded as
it would be in the surgical site underneath the transverse carpal
ligament for shielding tissue, such as nerves and tendons, from the
site of the transection of the transverse carpal ligament; and,
FIGS. 10A and 10B are illustrations of a protective sheath adjacent
the energy discharging conduit for preventing sticking of the fiber
of tissue and providing a self cleaning action.
FIGS. 11A, 11B and 11C are respective sections of the wrist, palmar
side of the hand, and back side of the hand;
FIGS. 12A and 12B are respective illustrations of the anterior and
posterior portions of a human foot;
FIG. 13 is an illustration of the planar side of the foot to show
the tarsal tunnel;
FIG. 14 is a section in the skull adjacent the mandibular joint;
and,
FIGS. 15A-15B are representative illustrations of two positions of
female breast augmentation implants with FIG. 15C being a schematic
of a procedure preferably utilizing the semirigid probe of my
invention; and
FIG. 16 is a schematic of the human elbow.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring to FIG. 3, a pistol grip G having a protruding probe P is
illustrated. The probe P is being placed within a longitudinal
incision within hand H. Insertion occurs through a longitudinal
incision I at the distal volar of the forearm at the base of hand
H. An alternate incision for insertion of the probe is shown at
I'.
The gross manipulation of the disclosed surgical instrument having
been described, its operative portions can be set forth.
Referring to FIG. 4A, a pistol grip G is illustrated with probe P
protruding from the "gun barrel" position relative to the grip. It
will be understood that since the subject of this invention relates
to surgery in small and confined places, the probe is made as small
as practical. Further, the probe--and all its contents--are can be
semirigid. That is to say, the stiffness of the probe is sufficient
to permit insertion; but flexible enough to accommodate blunt
dissection at the tip of the probe so that the probe P finds its
way between anatomy structures without incising them. This being
the case, the reader will understand that the drawings illustrating
the best mode of this invention contemplated at this time are not
necessarily to scale; such dimension may be added by the
routineer.
A minimum of two conduits are required for probe P. The first
conduit is for an optical viewing device O. Optical viewing device
O can have any standard configuration. Preferably it comprises an
optical fiber 14 having a wide-angle lens 16 at the end. The
optical fiber is connected to a viewing device 20, which viewing
device can either be an eyepiece or a monitor for displaying the
field of view seen at lens 16. I contemplate other viewing devices
including remote and miniature video cameras.
Secondly, the probe must include a conduit 38 for transmitting
energy sufficient for transection of the transverse carpal
ligament. Conduit 30 terminates at end 34 where the energy within
the conduit is discharged from tip 36 at the surgical site. This
discharge must occur within the field of view of the lens 16 so
that transection occurs within the view of the surgeon.
In the embodiment here shown, an optical fiber 38 connects to a
laser power source including a laser amplifier. The optical fiber
is capable of in-and-out motion with respect to conduit 30; thus
the fiber as shown is maneuverable with respect to the probe P. For
example, I have constructed the probe from a hypodermic needle
having a bent end; an optical fiber was moved with an "in-and-out"
motion with respect to the hypodermic needle. An optical fiber
viewing device was taped to the needle. The device was sufficient
for surgery related to the transection of the transverse carpal
ligament.
It will be found convenient to rotate probe P with respect to grip
G. Such rotation is schematically shown at arrow 66.
Referring to FIG. 5A, I illustrated the probe P at the blunt
dissector end 61 of the probe. It will be seen that the opening 62
of the probe P defines a suction entrance volume 62, this volume
having multiple purposes. First, and most apparently, it draws the
smoke and soot of surgery away from the view between lens 16 and
tip 36. Secondly, and as the probe advances, it defines an upwardly
exposed cavity in which the disclosed surgery can occur. Finally,
and at pad 63, a relative hard spot is defined at the tip of the
probe P whereby structure can be impressed (felt) with the probe
P.
I contemplate construction of the probe from molded, semirigid
construction materials such as those selected from plastics
commonly used in surgery. Naturally, other materials will
suffice.
Referring to FIGS. 5B and 5C, I disclose a conduit 34 having an
energy fiber which is maneuverable with respect to the end of probe
P. Specifically, the motion here illustrated is side-to-side and
up-and-down motion. Such motion is well known. By way of example,
endoscopes commonly accommodate such motion at their tips. An
example of such an endoscope is Nasal Endoscope manufactured by the
Makatsu Corporation of Tokyo, Japan. While this endoscope is larger
than the fiber steering conduit I contemplate, this is a matter of
scale.
Referring to FIG. 6, the operation of steering function can be
understood. Specifically, a semirigid end 40 is provided around
conduit 30. Tensile elements 42, 43 are provided along the side
walls of the semirigid end 40. As is well known, by providing
differential tension on elements 42, 43, remote steering of probe P
at the distal end can occur. I prefer to place wires 42, 43 to a
knurled wheel 50 for the side-to-side direction of the optical
fiber. Up-and-down motion can be directed by wire 55 connected in a
similar manner to trigger 52 on grip G (not shown in FIG. 6.
The reader will appreciate it may be desirable to move the optical
viewing device independent to the probe and energy fiber at tip 36,
construction will duplicate the structure shown for moving fiber 34
at tip 36.
In the preferred embodiment illustrated in FIG. 4A, I include a
suction conduit 60 with an end 61. As can be seen in the side
elevation of FIG. 4A, end 61 is distal to both the end of the fiber
36 and lens 16. Suction conduit 71 is connected to suction pump
64.
FIGS. 5B and 5C show respective side/plan elevations of the suction
only. It can be seen that opening 62 and end 61 of suction conduit
60 is disposed immediately underneath end 36 of fiber 34. In this
disposition, and during the surgery, smoke and soot that might
obstruct the view of end 36 of fiber 34 are removed. The field of
view from lens 16 is schematically shown.
Referring to FIG. 7, I illustrate two additional features of my
invention. First, I illustrate grasping devices utilized in
combination with probe P. The surgical grasping device contemplated
is manufactured by the Acuflex Corporation of Mansfield, Mass. This
device includes blunted, opposed jaws 70 at the tip with a scissors
like handle 72, which scissors like handle 72 can be rotated
remotely from the instrument. I choose not to illustrate the pistol
grip G for ease of understanding. In the current embodiment,
limited towards and away motion is provided by handle 72 as well as
rotation.
It will be seen that in the schematic of FIG. 7, I illustrate a
tissue member 80 being grasped, with tip 36 having just severed its
outer portion with disposal to underlying suction entrance 62.
Severing on either side of grasping device 70 is contemplated.
FIGS. 7, 8, 9A and 9B illustrate my instrument with an additional
attachment.
Referring to FIGS. 9A and 9B, the exterior of the probe P is
covered with a flexible mesh structure 70 attached to the tip of
probe P. Flexible mesh structure 70 in the collapsed position
illustrated in FIGS. 9A. Flexible mesh structure is attached at 75
to a sleeve 72 on probe P. Other reciprocating members sliding
along the distal end of probe P may also be used. Attachment to end
61 of probe P occurs as well.
To maintain the flexible mesh structure 70 in the closed position,
sleeve 73 biases flexible mesh structure 70 away from the end of
probe P. (See FIG. 9B).
Referring to FIG. 9B, opening of flexible mesh structure 70 on the
end of probe P can be understood. Sleeve 73 is moved forwardly.
Flexible mesh structure 70 expands away from the sides of probe P
while remaining attached to the distal end of probe P.
It is important to observe that flexible mesh structure 70 only
covers the bottom of the probe P below suction conduit 60 at end
61. That is to say, with respect to the longitudinal axis of probe
P illustrated, only that portion of the probe P disposed away from
the transverse carpal ligament is shielded, the shielding occurring
for approximately 180.degree. around the axis of probe P.
The function of the flexible mesh structure 70 is easy to
understand. Specifically, tendons and nerves (See FIG. 2) within
the carpal tunnel are shielded and kept away from the transection
surgical site.
Referring back to FIG. 8, it will be understood that the deployable
shield that I contemplate can be a balloon 100. Typically, balloon
100 is fastened to the sides of the probe P, just below suction
entrance 62. It extends around the bottom circumference of the
probe--it does not extend over suction entrance 62. Inflation and
deflation occurs through conduit 65. In this disposition, preferred
protection in the format of a deployable shield is provided.
Referring to FIGS. 10A and 10B, I contemplate a self-cleaning and
protective sheath 120 over fiber end 34 covering tip 36. Simply
stated, controlled in-and-out motion (pistoning) is contemplated.
Since tip 36 is in effect active, tissue will adhere. Further, upon
advance of the probe P, tip 36 could become impaled. This being the
case I contemplate a cover 120 having spherical end 121 with
serration 122. When the tip 36 is retracted, cleaning of the fiber
end occurs. In the retracted position, advancement with reduced
risk of impalement can occur. For use, fiber 34 is advanced out of
sheath 122 opening spherical end 121 at serration 122.
Presuming the skill and knowledge of a hand surgeon, the operation
is easy to understand.
In the disclosed operation process, anesthesia is provided and a
longitudinal incision I is made at the distal polar of the forearm
(or wrist). Optimally, a solid probe having the overall dimension
and cross section of probe P is inserted to create a temporary
tunnel for the probe of the instrument. This typically occurs with
a transitory compression of the median nerve 20 (See FIG. 2).
The probe P of the instrument is then inserted underneath the
transverse carpal ligament T, and the ligament visualized for its
entire span. The suction pump 64 is turned on and transection
commenced by the discharge of energy from the optical fiber 34 at
end 36. Appropriate in-and-out, side-to-side, and up-and-down
movement of the fiber 34 at end 36 in conducted under the view of
the surgeon through lens 16. During the discharge of the
transecting energy, conduit 60 with the suction draws the smoke and
soot of the laser surgery out of the field of view of the
orthoscope. Surgical shield 70 is preferably deployed. When the
transverse carpal ligament is transected, the probe is withdrawn,
the longitudinal incision sutured closed and the hand placed in a
post surgical splint for recovery.
FIGS. 11A and lib illustrate the wrist joint and these are the
portals of entry and there are six reference portals which you can
insert my probe for the purpose of entering the joint and treating
problems within, inside the wrist.
In the cross-section the portals are labelled between the six
extensor compartments in the back of the hand, named with 201-205
going from the radial side, which is the thumb side, to the ulnar
side, which is the little finger side. So, between the first and
second extensor compartment are portals 201, between the third and
fourth extensor compartment there is a portal 202, between the
fourth and fifth extensor there is a portal 203, and on either side
of the sixth extensor compartment is a portal 204, 205, the portal
being a zone of entry. That is with the joint between the forearm
bones and the wrist bones.
Now with respect to each one of those portals at the wrist, they
basically meets my qualification if the surgical site is a joint
and a probe is inserted to it, the probe, in reaching the surgical
joint, is going to be constrained. Proximal manipulation of the
probe in order to effect the movement of the distal end of the
probe P for surgery is impracticable. Rather, it is going to be the
movement at the distal end of the probe P that is going to do the
surgery.
Referring to FIG. 11C, the same thing holds true for the other
wrist joint, which is the midcarpal wrist joint, which is
illustrated with respect to the back side of a hand. Two surgical
portals 208, 209 for the midcarpal joint. These particular portals
are between the proximal and midcarpal bones interspaced between
the extensor tendons as shown.
Referring to FIG. 16, the structure of the elbow is illustrated.
The posterolateral portal 301, the straight posterior portal 302,
the anteromedial portal 303, the anterolateral portal 304, and the
straight lateral portal 305 are schematically shown. These portals,
and the surgical sites underlying them, generally meet the
qualifications that proximal movement of the probes to accomplish
distal movement of the energy discharging fiber is not practical
because of either the constraint of the surrounding tissue or
possible damage to the surrounding anatomy.
And the reason that there are so many portals in the wrist, unlike
the knee, is again because the knee permits proximal manipulation
of the device to get to your operative site, whereas in the wrist
you cannot really manipulate this proximally to get to all fields.
That is why it is required to specify so many different, separate
portals in this area of the human anatomy.
Regarding the portals of entry to the foot at the ankle, these
again have the same problem. Referring to FIG. 12A, from the
anterior aspect of the foot, which is the opposite side of that
which is walked on, is illustrated coming toward the viewer. You
walk on the plantar surface and the side that you put the scope in
is either in the anterior (FIG. 12A or the posterior part (FIG.
12B), which is by the Achilles tendon. So, there are three anterior
portals 210, 211, 213, and three posterior portals 214,215, 216,
being anterior lateral, anterior central, anterior medial;
posterior being posterior lateral, trans-Achilles (which means you
go right through the Achilles tendon) and the posterior medial
portal. Again, the problem here is that, the reason we have so many
portals is because of the limited space in that joint, unlike the
knee, which means you cannot manipulate the instrument proximally
in order to get the distal end of the probe to move for operative
engagement within the surgical site. As I disclose with my
preferred probe, all movement has to be in the operative site at
the distal end of the probe without concomitant movement of the
proximal side.
Referring to FIG. 13, the plantar side of the foot to demonstrate
surgical ports of entry having the same constraints. It is to be
noted that like in the hand where there is a carpal tunnel, in the
foot there is tarsal tunnel T'. The tarsal tunnel is like the hand
in the sense that there are tendons, nerves, and blood vessels
going through a space, which has a fixed boundary on three sides,
except for the fourth boundary, which is a ligament. That ligament
basically is the soft structure. Anything that causes increase in
content volume in that space will cause pressure on the structures
within that space and the structure most sensitive to pressure is
the nerve causing symptoms. Again, the disclosure herein sets forth
a surgical probe instrument that is ideal for that because it
permits transection of that tunnel without a fairly large incision
on the bottom of the foot, which would take a long time to
heal.
Entry occurs on either the plantar surface of the foot 221, or
preferably the instep 220.
Referring to FIG. 14, the temporomandibular joint is illustrated.
That is the joint in the jaw where the mandible meets the cranium
or the skull. The condyle 225 of the mandible; the articular disk
226; the cranial base 227; the ear canal 228; the front F of the
person; the back R of the person. The points of entry are directly
in front of the ear canal 231 or in front of the condyle.
Potentially, there are four entry points.
Referring to FIG. 15A, 15B and 15C, a female breast is illustrated
having an implant 264. The breast implant 264 is shown in 15A and
15B following breast augmentation. The implant is shown in FIG. 15A
above the pectoralis muscle or below the pectoralis muscle. In
either case, a capsule or scar tissue 260 forms around the implant
264.
In FIGS. 15A and 15B, implant 264 is shown within a scar tissue
capsule surrounding the implant 264. Breast tissue 261, the
pectoralis muscle 262, and the anterior rib cage 262 are also
shown.
As is well known, the scar tissue of the capsule can either
contract or shrink. The breast implant becomes hard. Nerves can
either be directly affected by the scar tissue or alternatively the
implant itself can pinch a nerve.
The way this problem is treated with the probe is by incising this
capsule in a star pattern or cartwheel pattern, see FIG. 15C at
270, dividing the scar, allowing the implant to roam in a bigger
pocket, The implant becomes softer again.
The probe P of this disclosure would enter either through the side
(not shown) or through the areolar area just to get to the implant
at the interface between the implant and the capsule. In such
penetration, access to the scar tissue is desired; injury to the
implant is to be avoided.
It will be appreciated that in such a procedure, my probe P will be
particularly useful if it is of semirigid construction.
It will be understood that surgery by knife is excluded from the
contents of this disclosure. Further, It is preferred to utilize
laser energy. Laser energy ranges sufficient for the performance of
the surgery set forth in this invention for the transection of the
transverse carpal ligament are contained in U.S. patent application
Ser. No. 07/621,451 of Peter S. Hertzmann and Jordan K. Davis filed
Nov. 30, 1990 and entitled A METHOD FOR PERFORMING PERCUTANEOUS
DISKECTOMY USING A LASER, issued as U.S. Pat. No. 5,201,209. This
application is a Continuation-In-Part of U.S. patent Ser. No.
07/463,759 filed Jan. 12, 1990. This application and especially its
laser frequency ranges are incorporated to this disclosure by
reference.
It will be apparent, that the disclosed operating probe will be
applicable to other operating sites in the body. In an application
filed of even date herewith, It is specified by location operation
sites. These operating sites are all adjacent to constrained
cavities having narrow substantially nonmanipulable entrance
confines. These narrow substantially nonmanipulable entrance
confines inhibit, retard and practically prevent appreciable
side-to-side motion of a probe. That is to say, the probe can not
be manipulated at its controlling end other than accommodating in,
out and rotation. The whole surgical movement of the system has to
occur at the distal end--and not by side-to-side motion of the
probe at the controlling end.
It will be understood that this specification is exemplary and the
invention herein to be liberally construed within the scope of the
attached claims.
* * * * *